FDA AdCom backs nirsevimab as first immunization against RSV disease for all infants
The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) yesterday voted unanimously 21 to 0 that nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in new-borns and infants born during or entering their first RSV season.
Under development by the UK’s AstraZeneca (LSE: AZN) and French pharma major Sanofi (Euronext: SAN), the new monoclonal antibody drug, is sold under the name Beyfortus and is already approved in Europe, Canada and the UK.
The Committee also voted 19 to 2 in support of nirsevimab’s favorable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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